510(k) K050869 ยท CIG Diazo Colorimetry, Bilirubin
MODIFICATION TO ABL800 FLEX
| Applicant | Radiometer Medical Aps, Washington DC, US |
| Decision | Substantially Equivalent, Aug 11, 2005 |
| Received | Apr 6, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050869
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2006 | Radiometer America Inc Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer Terminated |
JQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.